Qc, Supervisor Chemistry Jobs

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
The Supervisor of Quality Control Chemistry will be responsible for ensuring that day-to day QC Chemistry laboratory operation is performed in a manner that is compliant with GMP/FDA regulations, AAA and Novartis standard operating procedures. Due to the nature of the process (radioactive) this role requires basic proficiency, ownership of the quality control techniques, and understanding of radiation safety standards.
Position requires strong influence, analytical competency, risk-based decision-making capability, and leadership competency. Position will support both commercial and Technical Transfer business. Key business partners will be Operations, Site Quality and MS&T.

• Writing, review and approval of documents needed for laboratory operation, such as SOP’s, methods, specifications, change control requests, etc.
• Select, train, supervise laboratory personnel in the performance of the testing procedures required to meet regulatory and scientific standards for pharmaceutical products. Staff performance management and development
• Conduct or delegate laboratory investigations, including OOS/OOT/OOEs, and deviations.
• Ensure stability testing is performed in alignment with applicable GMP/FDA regulations, AAA and Novartis standard operating procedures at Indianapolis facility.
• Manage QC KPIs (timeliness, training, testing cycle time, periodic review, etc.)
• Act as Subject Matter Expert in his or her area of expertise: primary contact for troubleshooting, deviation/OOS investigations, assess product and environmental data and performs trending, and QC documentation management
• Collaborate with Global organization to resolve any analytical testing problems, recommend appropriate changes, if required.
• Oversee day-to-day operation of QC Chemistry laboratory
• Keep up with industry trends and best practices. Drive spirit of continuous improvement to ensure Inspection readiness state.
• Act as designee and make key decisions regarding quality control processes in the absence of the Manager, QC Chemistry.
• Supports all technical aspects related to quality control testing readiness including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing.
• Ensure QC events are categorized and escalated timely.
• Facilitates a culture of “speaking up” and ensuring all cGMP compliance activities are followed
• Support regulatory inspections and audits

The pay range for this position at commencement of employment is expected to be between $88,000 and $132,000 year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Education: Bachelors degree in relevant scientific discipline (e.g. chemistry, biology, etc.).
Experience / Professional requirements:
Practical experience in physico-chemistry techniques, microbiology.
Minimum of 3-5 years' experience in Quality Control in cGMP or aseptic environment required.
Good Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for product and raw material testing, and familiarity with analytical equipment.
Languages: Fluent in speaking / writing in English
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

ONCOLOGY

ADVANCED ACCELERATOR APPLICATIONS

USA

Indianapolis, IN

AAA USA Inc.

Quality

Full Time

Regular

No

No